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The below web-clip is from Daval's website. They are calling the Optic Neuritis trial a "significant success". I am concerned, though, that they mention statistical significance in tertiary outcome measures. Does that mean that their primary and secondary measures were not significant? And how many people were in this trial....? Lots of information yet to be released.

Once they get their journal articles accepted and in-press, I hope they'll be available, somewhere...

Britain’s 80,000 Multiple Sclerosis sufferers have been given fresh hope following the success of an independent clinical trial of Aimspro.

MS patients with the condition Optic Neuritis – an inflammation of the optic nerve and one of the most common features of multiple sclerosis - were treated with Aimspro in a recent clinical trial at Oxford University and the John Radcliffe Hospital.

Patients’ vision improved significantly following treatment with Aimspro. The trial participants demonstrated improvement in objectively measured visual field scores over a two week course of treatment, under double blind conditions - and they experienced no side effects as a result of the treatment.

These highly significant improvements in the patients sight were observed after only three sub-cutaneous injections – and the possibility of a placebo effect was excluded.

This is the first time that any treatment has been shown conclusively to reduce an aspect of disability in the chronic phases of MS to this degree.

The Aimspro trial at the John Radcliffe was a randomised, double blind, placebo controlled, crossover trial, independently designed and analysed by two of Britain’s leading MS experts, Prof. Paul Matthews and Dr. Jackie Palace, and their research fellow Dr. Georgina Burke. Patients and researchers were ‘blinded’ as to whether participants were receiving Aimspro or placebo. The crossover design meant that each patient received two weeks (three injections) of medication, and two weeks of placebo, each phase separated by a ‘washout’ period.

In tertiary outcome measures, there was a significant treatment effect on visual fields in both of the assessed measures (p=0.02 for manual points score, p=0.03 for Mean Deviation score). The report also mentions that the treatment was 'well tolerated' (i.e. there were no significant side effects).

Optic neuritis is a complication of MS where discomfort behind the eye is followed by a loss of central vision (particularly colour vision) as demonstrated using visual field testing. Generally patients’ vision recovers fully or partially as an attack of MS on the optic nerve ceases, but some have their sight permanently affected. The patients in the Oxford trial had entered a chronic phase of visual loss, with little chance of significant improvement. All the trial patients have requested to remain on the therapy.

Dr BryanYoul, a consultant in Clinical Neurophysiology at the Royal Free Hospital in London, whose own findings on the medication’s application in MS and other neurological conditions are about to be published in the UK and Australia, is hugely encouraged by the Oxford trial results.

“These trial results are hugely significant and have wider implications for the treatment of MS. Although this was a small trial, the Oxford Neurologists have shown that a brief course of three well tolerated sub-cutaneous injections of Aimspro, can demonstrably improve the condition of MS patients. And they echo other clinical observations which show this drug is able to improve mobility, bladder control and energy levels among MS patients.”

The Oxford trial confirms Dr Youl’s own findings in observational studies carried out last year in London.

He said:

“Within one hour of injection there was a significant improvement in colour vision, and comparison of pre-treatment and follow-up data also showed significant benefit.”

He added:

“Aimspro has a powerful and often rapid effect, producing dramatic improvement. We believe it to be restoring conduction in nerve and muscle fibres damaged by MS and other central and peripheral nervous system disorders, probably by an effect on biological structures within nerve and muscle known as voltage gated sodium channels.There is also clinical evidence to suggest that there may also be a repair process taking place in the longer term, which may reflect the medication’s powerful anti-inflammatory properties”.

Dr Youl is now working with UK and Australian colleagues, on confirming his early observations on the effect of Aimspro in leucodystrophies, inherited and inflammatory peripheral neuropathies, and a range of rheumatological disorders, and muscle disorders.
Dr Bryan Youl has shown that patients with long standing complications of optic neuritis can benefit from the medication, which is given as an injection under the skin, in as little as 25 minutes. Simple neurophysiological tests verified that this phenomenon results from a reversal of ‘conduction block’ in optic nerve fibres. Dr Deidre McIntosh PhD has identified molecules critical to the mechanism of action. Dr Chris Moore FRCP has confirmed neuroscientists’ expectation that modification of sodium channel triggering is critical to the process.

The Oxford/John Radcliffe team intend to publish their analysis of the trial results in a clinical scientific journal later this year.

The trial at St George's Hosp. was stopped because the hospital failed to follow agreed protocols on the handling (& storage of the product) in a way that was very likely to have rendered it substantially less effective. I believe it might have been allowed to thaw quite some time before administration.

To have continued would have risked both producing unrealistically poor results and leaving an opportunity for criticism about poor procedure (even though the company have no influence after supplying the product).

It would also have continued to be a drain on this very small company's resources.

There is a short outline statement about the cancelled trial on the company's website but it has been overshadowed by the ON news item.

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